Dental titanium bases recalled because the post is oriented 180 degrees off
NobelBiocare Tri-Lobe-compatible WP 6.0mm engaging titanium bases, lot 277097, are recalled because the base was manufactured 180 degrees around the post from the correct position. 11 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the stated consequence is a restoration delay rather than any described patient harm.
Plain-English summary
The NobelBiocare Tri-Lobe-compatible WP x 6.0 mm Engaging Titanium Base, REF 9000662, UDI-DI 00842092169599, lot 277097, is being recalled. The recall covers 11 units distributed in New York, Florida, Pennsylvania, California and Ohio.
The engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry. If the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correct orientation, resulting in restoration delay. The FDA classified the action as Class II.
Dental practices and laboratories holding this lot should quarantine it and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
- Manufacturer
- Preat Corp
- Affected units
- 11
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00842092169599. Lot: 277097
Distribution
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